Phase II Study of Atezolizumab and Tiragolumab for HPV-positive Squamous Cell Carcinoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06762808

Provider View

This clinical trial is testing a combination of two immunotherapy drugs, atezolizumab and tiragolumab, for patients with HPV-positive squamous cell carcinoma who still have detectable HPV DNA in their blood after completing standard treatment.

Patient Parameters

Program Overview

The study aims to find out if the combination of atezolizumab and tiragolumab can help patients with HPV-positive squamous cell carcinoma stay cancer-free for a year after treatment. It will also look at how often the cancer comes back or spreads, and how safe the treatment is for patients.

Description

This study is focused on patients with HPV-positive squamous cell carcinoma who have completed their initial treatment but still have detectable HPV DNA in their blood. The main goal is to see if the combination of atezolizumab and tiragolumab can help these patients remain free of cancer for a year. Researchers will also monitor how often the cancer returns or spreads to other parts of the body, and assess the safety and side effects of the treatment. Additionally, the study will measure how well the treatment clears HPV DNA from the blood.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage I-III HPV-positive squamous cell carcinoma in areas like the anus, cervix, head and neck, penis, vagina, or vulva.
  • Completed standard treatment (radiation, chemotherapy, or surgery) at least 12 weeks ago.
  • No signs of cancer according to the treating doctor.
  • Detectable HPV DNA in the blood at least 12 weeks after finishing treatment.
  • Age 18 or older.
  • Able to understand and sign a consent form, with help from a medical interpreter if needed.
  • Able to follow the study procedures.
  • Good overall health with specific blood test results within normal ranges.
  • Negative tests for HIV, hepatitis B, and hepatitis C, or these conditions are well-controlled.
  • Women and men must agree to use effective birth control during the study and for a period after the last dose of the study drugs.

Exclusion Criteria

  • Have a different type of cancer than squamous cell carcinoma.
  • Have signs of cancer at the time of joining the study, unless the cancer is shrinking after treatment.
  • Have uncontrolled high calcium levels in the blood.
  • Have had surgery to treat cancer that didn't respond to radiation.
  • Are receiving other experimental treatments or have had such treatments recently.
  • Have active cancer treatment or have had standard treatments recently.
  • Have mental health or social issues that would make it hard to follow the study.
  • Have certain autoimmune diseases or immune deficiencies, with some exceptions.
  • Have significant heart disease or have had a major surgery recently.
  • Have had another cancer within the last 3 years, with some exceptions.
  • Have had a severe infection recently.
  • Have had a stem cell or organ transplant that requires immune-suppressing drugs.
  • Have received a live vaccine recently or plan to during the study.
  • Have a positive test for Epstein-Barr virus.
  • Have had certain immune therapies before.
  • Are pregnant or breastfeeding, or plan to become pregnant during the study.

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